Beyond Tableting Lubrication – PRUV® by JRS Pharma
PRUV® by JRS Pharma is a tablet lubricant designed for formulations in which other lubricants lead to formulation and/or manufacturing challenges. As opposed to the frequently used lubricant, magnesium stearate, PRUV® offers the following advantages:
- High degree of API compatibility*
- Robustness to over-lubrication
- No adverse effect on bioavailability
- Improved appearance of effervescent solutions.
PRUV® helps to accelerate product development and is particularly well suited for high-speed direct compression of tablets.
*Reported API incompatibilities with magnesium stearate include: Azathioprin, Cefaclor, Cilazapril, Clopidogrelacetate, Dicofenac, Fosinopril, Ibuprofen, Ketorolac, Levofloxacin, Nifedipine, Omeprazole, Ramipril, and Trandolapril.
Physical Properties of PRUV®
- White, fine powder
- Less hydrophobic than magnesium stearate
- Anti-adherent properties
- High melting point
- Controlled particle size
- Well defined specific surface area
- Lamellar structure
Applications
- Wet granulation
- Dry granulation
- Capsules
- Direct compression
- Continuous manufacturing
- Hot melt extrusion
Benefits of PRUV®
- Improved drug stability
- Shorter disintegration times
- Faster dissolution rates
- Enhanced lubrication efficiency
- Less sensitivity to blending time
- Reduced probability of overblending
- Harder tablets in comparison to tablets produced with magnesium stearate
- Due to its high melting point, PRUV® is also an ideal lubricant for hot melt extrusion.
- Physical Properties of PRUV®
- Excellent batch-to-batch consistency
- Faster formulation development and scale-up
Sodium Stearyl Fumarate2
Ph. Eur., NF, JPE, FCC
Watch our Product Video PRUV®
PRUV® vs. Magnesium Stearate
PRUV® helps to avoid API incompatibilities and enhances API stability. With a few exceptions, PRUV® can be applied to any formulation for lubrication, particularly those in which API stability or tablet taste is compro- mised due to magnesium stearate.
Because the magnesium cation (Mg ) is electrophilic, 2+ it interacts with the free electrons of an API and forms insoluble salts. This is one of the many causes of API incompatibility with magnesium stearate.
Electrostatic Properties
Magnesium stearate shows higher voltage and retention times than PRUV®. Low electric charge and retention improve lubricant dispersion during blending. As a result, PRUV®, due to its low voltage and retention, can be considered a superior lubricant with improved lubricant uniformity.
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Source: JRS Pharma, website PRUV® (jrspharma.com)